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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CS Imaging Suite - 60192155943010

CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution

  • 60192155943010 ()
5943014

  • General-purpose dental x-ray system application software

Logicon Caries Detector - 60192155942754

CSD LOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Logicon Caries Detector
In Commercial Distribution

  • 60192155942754 ()
5942750

  • General-purpose dental x-ray system application software

Trophy Imaging 8 - 60192155500688

Trophy Imaging 8
CARESTREAM DENTAL LLC
Trophy Imaging 8
In Commercial Distribution

  • 60192155500688 ()
5500681

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155500671

CS IMAGING 8 SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155500671 ()
5500673

  • General-purpose dental x-ray system application software

Trophy 3D Imaging - 60192155319556

TROPHY 3D IMAGING
CARESTREAM DENTAL LLC
Trophy 3D Imaging
In Commercial Distribution

  • 60192155319556 ()
5319553

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155314308

CS Imaging Suite
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155314308 ()
5314307

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924122050

EVA SELECT SIZE 2 SENSOR
ImageWorks
9992412205
In Commercial Distribution

  • D83399924122050 ()
9992412205

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924121050

EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software

Samsung Sleep Apnea Feature (Android OS) - 08806094936889

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software

Samsung Sleep Apnea Feature (Wear OS) - 08806094936872

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936872 ()


  • Patient general health self-management software
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